a. Field of the Invention
The present disclosure relates generally to a robotic control and guidance system (RCGS) for one or more medical devices. More particularly, the present disclosure relates to a drive assembly for use in a RCGS that comprises, for example, a manipulation base and a medical device cartridge for a medical device, such as, for example, a spiral mapping catheter.
b. Background Art
Electrophysiology (EP) catheters are used in a variety of diagnostic and/or therapeutic medical procedures to correct conditions such as atrial arrhythmia, including for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Arrhythmia can create a variety of dangerous conditions including irregular heart rates, loss of synchronous atrioventricular contractions and stasis of blood flow which can lead to a variety of ailments.
In a typical EP procedure, a physician manipulates a catheter through a patient's vasculature to, for example, a patient's heart. The catheter typically carries one or more electrodes or sensors that may be used for mapping, ablation, diagnosis, and the like. Once at a target tissue site, the physician commences diagnostic and/or therapeutic procedures. Such procedures require precise control of the catheter during navigation, and delivery of therapy, to the target tissue site, which can invariably be a function of a user's skill level.
Robotic control and guidance systems (RCGS) for one or more medical devices (or robotically controlled medical device guidance systems) are known to facilitate such precise control. In general, these types of systems carry out (as a mechanical surrogate) input commands of a clinician or other end-user to deploy, navigate, and manipulate one or more medical devices, such as, for example, a catheter and/or an introducer or sheath for a catheter, or some other elongate medical instrument. One exemplary robotic catheter system is described and depicted in U.S. Patent Publication No. 2009/0247993 entitled “Robotic Catheter System,” the entire disclosure of which is incorporated herein by reference.
While such systems have proved useful with respect to providing, among other benefits, precise control as described above, the particular use of an RCGS to perform mapping functions with certain medical devices (e.g., spiral mapping catheters) has proved complicated. This complexity is generally due to the fact that the these medical devices must be rotated into pulmonary veins. This presents a number of difficulties or issues. For example, one such issue relates to how a rotary or spiral catheter having multiple control actions (i.e., three-axis motion—translation, rotation, and the occlusion of the loop at the distal end of the device) and multiple sensors (e.g., electrodes), which, in some instances may number in upwards of twenty-four (24), can be manipulated without excessively complex mechanical or electrical interfacing.
Another issue relating to the use of an RCGS with a rotary or spiral medical device relates to how to shield the medical device and other components disposed in a sterile field (e.g., the table, drapes, the patient, etc.) from contaminants, and therefore, maintain sterility, when a non-sterile manipulating system is used.
Accordingly, the inventor herein has recognized a need for apparatus, such as, for example, a drive assembly and the constituent components thereof, for use with a RCGS that will minimize and/or eliminate one or more of the deficiencies in conventional systems.